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Companies, like individuals, must stay in shape, and both must search-in an environment of high demands on time and resources-for the right tools to achieve and maintain fitness. The pharma industry's current challenges suggest that the need for fitness may be greater than ever:

A jittery stock market, repeated profit warnings, concern about accounting practices, another industry mega-merger, and a new raft of legislative proposals. Small wonder that US analysts find it difficult to separate the words "troubled" and "pharmaceutical industry."

FDA's September announcement that it plans to transfer some therapeutic biologic review functions from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER) caught most agency officials and Washington observers by surprise.

I was wondering whether I could take any more pain, when the moment slowed to a crawl. Pain wakened fear. Eternity lingered alongside. Mortality, grinning over my shoulder, blew a chill breath across the nape of my neck. "Dying would end the pain," I thought. "But I don't want to die like this."

Rarely does the head of a top pharma company agree to meet with a journalist in the midst of a strategic challenge as large as this one-Merck's plan to establish Medco Health Solutions as a separate, publicly traded company.

Is a pharma website a type of labeling, a form of advertising, or some new hybrid? The industry has used the internet as a communication channel since 1994, yet, after nearly a decade of online medical development and experimentation, none of the major regulators has decided yet-or offered any clear guidance about-what constitutes "acceptable use."

I thought I knew all of the definitions for healthcare compliance when I left my job at a traditional pharma company in 1998 to become chief operating officer of a company that sold both medical diagnostics products and pharmaceuticals.

A major consolidation may be underway in the UK biotech sector. According to a report in London's Financial Times, several embattled companies specializing in cancer medicines are talking about a possible merger. Xenova, British Biotech, Antisoma, KS Biomedics, and Oxford GlycoSciences are believed to be in the early stages of discussions about merging to create a much stronger company.

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For everyone from legislators to healthcare payers to corporate executives, generics is the new hot topic. First, the Greater Access to Affordable Pharmaceuticals Act of 2002, which would eliminate the 30-month delay that is triggered when a brand-name company sues a generics maker for patent infringement, passed the US Senate and is under consideration in the House.

For years, medical education activities have been a sure way for pharma marketers to deliver key messages to the medical community about scientific discoveries, new treatments, and products fostering medical advancement. The most effective activities advance physicians' knowledge and motivate them to act.

Many more high-risk patients could benefit from statin therapy than currently receive the cholesterol-lowering drugs, according to a major UK study set up by the Medical Research Council and the British Heart Foundation.

Forging Alliances

Successful partnerships with third-party organizations such as patient and caregiver advocacy groups, professional associations, and thought leaders are powerful medicine for pharma companies.

Pharmaceutical companies and their marketing partners face a common dilemma: how to translate scientific progress into market success. Despite huge investments, R&D never seems to produce an adequate number of products with blockbuster potential.

Top European Trial Sponsors

A CenterWatch survey of 545 European clinical trial investigators named the best pharma companies to work with in clinical development.

Spurred by concerns about rising drug expenditures, the Netherlands' government has introduced a list of "lifestyle" medicines that it intends to stop covering with its basic health insurance.

In a new twist on "direct mail campaigns," marketers at Eli Lilly have taken DTC to an unprecedented level. The company is currently under investigation by the Florida attorney general for allegedly mailing Prozac Weekly (fluoxetine) to a woman who did not have, or request, a prescription for the product.

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Pharma companies invested a hefty $12 billion in promoting to physicians and consumers in 2001, according to Scott-Levin. But after the highs of 2000, spending in 2001 seemed stunted-a growth rate of 9 versus 13 percent.

Sixteen years ago I began to edit Pharmaceutical Executive, a magazine unknown to me only a few months before. Today, I wonder how much I've learned in all the time since.

The number of pharmaceuticals derived from nature is staggering. Many medicine cabinet staples were first isolated from natural sources-penicillin from mold, quinine from the cinchona tree, digitalis (foxglove) for heart ailments, and the list goes on.

The Enron/Arthur Andersen debacle has been a painful warning that there is more to analyzing corporate performance than the smoke and mirrors that often pass for accounting and financial scrutiny. Indicators such as brand value, new product revenue, presence and percentage of business conducted in the US market, and sales growth provide more reliable criteria for companies' short and long-term prospects.

As healthcare struggles to reinvent itself, a confluence of major societal forces has irrevocably changed both the business world and the healthcare landscape.

If pharma companies want to be trusted sources of information in today's healthcare environment, they cannot afford to mislead anyone.

Donal Geaney and Tom Lynch, chairman/CEO and vice-chairman, respectively, of the troubled Irish pharma company Elan, resigned following intense pressure from investors.

Search engine positioning (SEP) is a critical component of any online marketing plan. It is the art and science of increasing a website's visibility among major search engines and directories with a strategically defined set of key words.

Just when pharma companies finally awake to the need for a good reputation, the stakes go vertical. The long-perceived and possibly illusory gap between shareholder behavior and public outrage suddenly disappears. And each company stands or falls on its revealed record.